NDA Submitted for Sublingual Film to Treat OFF Episodes in Parkinson's Disease

Apomorphine is currently available as a subcutaneous injection for use in advanced Parkinson's disease

Sunovion announced the submission of its New Drug Application (NDA) for apomorphine sublingual (SL) film (APL-130277) for the treatment of motor fluctuations (OFF episodes) associated with Parkinson's disease.

Apomorphine SL film, a dopamine agonist, is intended for on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. The novel SL formulation may potentially be used to treat OFF episodes up to 5 times throughout the day. Apomorphine is currently available as a subcutaneous injection for use in advanced Parkinson's disease.

The NDA submission included data from Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group study (CTH-300) that enrolled patients with levodopa-responsive Parkinson's disease complicated by OFF episodes. The primary endpoint was a mean change from pre-dose in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination at 30 minutes after dosing at the 12-week visit of the Maintenance Treatment Phase. The key secondary endpoint was the percentage of people with a patient-rated full ON response within 30 minutes at the 12-week visit of the Maintenance Treatment Phase.

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The study met its primary and key secondary endpoint as treatment with apomorphine SL film led to superior efficacy compared with placebo for the on-demand treatment of OFF episodes associated with Parkinson's disease. The clinical effect was observed until the last time point at 90 minutes. The study drug was also generally well-tolerated by the patients.

Apomorphine SL film has been granted Fast Track Designation by the FDA.